TBG hit a major fork in the road to selling its COVID-19 testing kits in Europe

It’s tough to sell anything in a foreign market if you can’t even get out of your home market, and that’s a dilemma now faced by TBG Diagnostics (ASX:TDL).

The company’s Chinese investee, TBG Biotechnology Xiamen, has a kit which it says can detect COVID-19. The three genes specifically are RDRP, N and E – the first of which is specific to COVID-19 while the others occur in other coronaviruses such as SARS.

The lack of tests has been a big impediment to tackling the epidemic.

Three weeks ago it received CE approval meaning the Chinese test could be sold in Europe. This led to TBG shares skyrocketing over 10 times to 27c.

The Chinese government has been keen to export test kits to other countries to cast itself as a world saviour. But it won’t just let any company send out kits.

Today it put a major impediment on TBG selling its test kits, saying the company can’t export without appropriate approvals.

“TBG Xiamen’s COVID-19 Virus Diagnostic Kits do not currently have Chinese medical device product certification required under the new export requirements as recently announced by the Chinese government. Therefore TBG Xiamen are currently unable to sell and export their COVID-19 Nucleic Acid Diagnostic Kits from China,” it said in a statement to shareholders.

It also confirmed it could not sell in China either because of it’s lack of local certification.

TBG says it intended to apply for the approvals. Once it has the approvals in hand, the company not only wants to sell them in Europe and China but throughout Asia and the US.

Stockhead has attempted to contact the company for further comment.

The ASX has kept TBG shares suspended since the news of the CE Mark approval pending further enquiries.

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